Recall Z-2150-2012— FMS, Finapres Medical Systems BV

Name: FDA recall Z-2150-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-06

Class II · Terminated

Class II FDA medical device recall by FMS, Finapres Medical Systems BV, initiated 2012-07-06, terminated 2012-09-12. It names one FDA 510(k) clearance: K023338. Product: Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.. Reason: Battery may become hot and leak.

Recalling firm: FMS, Finapres Medical Systems BV
Classification: Class II
Status: Terminated
Initiated: 2012-07-06
Terminated: 2012-09-12
Firm location: Amsterdam, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K023338 — PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2Fms, Finapres Medical Systems BV·cleared 2003-05-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

Reason for recall

Battery may become hot and leak

Data sourced from openFDA. This site is unofficial and independent of the FDA.